Current Status and Challenges of Alternative Methods for Potency Testing of Human Rabies Vaccines

Abstract

Rabies is a fatal viral disease, and vaccination is an effective means of prevention. Potency testing of rabies vaccines is crucial for ensuring vaccine quality. Currently, the NIH method is widely regarded as the gold standard for rabies vaccine potency testing; however, this method has limitations, including complexity, time consumption, and ethical concerns regarding animal use. In recent years, research in this field has gradually shifted towards alternative technologies aimed at improving testing efficiency, reducing costs, and addressing animal welfare requirements. This article reviews the research progress of various alternative technologies based on vaccine antigen detection and antibody detection, including enzyme-linked immunosorbent assay, time-resolved methods, rapid fluorescent focus inhibition test, and antibody binding test. It systematically analyzes the principles, technical limitations, and feasibility of these methods as alternatives in vaccine quality control, aiming to provide new insights and theoretical foundations for rabies vaccine potency testing to promote further development in this field.